Biopharmaceutical Senior Qc Planner Jobs

Establish production standards and manpower requirements to meet delivery schedules.

3+ years of leadership experience managing direct and indirect reports

Ensures good documentation and data integrity practices, by overseeing and approving improvements to standard operating procedures, batch document instructions, and logbooks

Prioritizes departmental technical objectives by using equipment and process data, historical performance, OE tools, and capacity of staff.

Ensures the appropriate accountability of cross-functional activities, such as engineering studies, validation studies and Tech Transfer studies

Pursues and proposes changes to current and emerging digital platforms (SAP, EBR, AR/VR, etc)

Advanced knowledge/experience with regulatory requirements, policies, and guidelines

Prior leadership experience, microbiology project management accepted

Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing

Detailed knowledge and experience in applying statistical concepts to laboratory data

Ensure accuracy and completeness of performed analytical method qualification, validation, and transfer activities

Set priorities and manage work assignments

Knowledge of basic laboratory skills and proper techniques for routine operation of analytical instruments

To ensure all test methods are in compliance with cGMP and Pharmacopeia requirements

To develop skills in analytical science and keep up to date with latest technologies in analytical science

Knowledge of personal protective equipment & its use (e.g., lab coats, safety glasses & shoes, etc.)

Knowledge of basic chemistry, advanced math including algebra

Experience of ICHQ2 Validation of Analytical Procedures

Performs other departmental duties as assigned by management

3+ years of analytical lab experience.

Physical requirements include stooping, standing, climbing and occasional lifting of up to 50 lbs

Good verbal and written communication skills

Perform testing following written methodologies and report results which are clear, defensible and right the first time.

Demonstrate awareness of the scientific principles and method validation for the assays which they perform.

Knowledge and skill required to manage and use automation and emerging digital platforms.

Knowledge and application of standard ERP processes in M-ERP following global and local procedures.

General knowledge of Microsoft Office Applications (Excel, Word, and Outlook)

1+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry.

Strong verbal and written skills

Perform the set-up, operation, cleaning and break-down of process equipment.

Establish production standards and manpower requirements to meet delivery schedules.

3+ years of leadership experience.

We are looking for professionals with these required skills to achieve our goals:

Ensures good documentation and data integrity practices, by overseeing and approving improvements to standard operating procedures, batch document instructions, and logbooks

Prioritizes departmental technical objectives by using equipment and process data, historical performance, OE tools, and capacity of staff.

Ensures the appropriate accountability of cross-functional activities, such as engineering studies, validation studies and Tech Transfer studies

Excellent project management and customer-facing skills

Adhering to Quality Management Systems and completing associated documentation

Bachelor degree in Biology, Biochemistry, Chemistry, Chemical Engineering, or related Science Field, or combination of equivalent education and experience

3+ years of experience in a leadership role

Extensive knowledge in either Upstream Production or Downstream Production activities and unit operations.

Knowledge of cGMP practices required

Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.

Expert knowledge of SOPs and Federal Regulations to include GLP and GMP

Expert knowledge of chromatography or other applicable analytical techniques and divisional SOPs

Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

Strong verbal and written communication skills

Reviews sample results for completeness and accurate representation of the data and reports findings.

5 – 10 years relevant business experience, including Vendor Management (preferred)

In-depth knowledge of and demonstrable skill in using continuous improvement methodologies and tools

Education, Certifications and/or Other Professional Credentials

Experience of delivering change in a complex, fast- paced environment

Outstanding customer service orientation and product knowledge

Strong written and verbal communication skills

Completion of a high school diploma or GED and a minimum 1 years of experience is required.

3-5 years experience which includes Quality and/or Industry experience is preferred.

Performs inspection of various operations activities.

Identifies and reports non- conformance to known standards using various measuring and testing methods.

Assures that all products and processes represent the desired quality, safety, efficiency and reliability levels.

8432 South Intersate 35W, Alvarado, Texas, 76009, United States

Demonstrated knowledge, skills, and abilities to perform the job functions of a leadership role.

Strong organization, time management, and planning skills and ability to manage multiple tasks with tight deadlines.

Builds strong relationships with customers, suppliers, production, management and all team members.

Bachelor’s Degree in related field required, or an equivalent combination of education and relevant experience.

Minimum of 6 years of experience as a manager.

Manages all aspects of quality.